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Feasibility Study of BMAC Enhanced CABG | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Feasibility Study of BMAC Enhanced CABG

Feasibility Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting(CABG) Surgery

NCT01074099•Harvest Technologies

View on ClinicalTrials.gov

Summary

Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium

Detailed Description

Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium. Control subjects will undergo CABG only

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age\> 18 years and ability to understand the planned treatment.
•Patients with ischemic congestive heart failure requiring by pass surgery
•Congestive heart failure with ejection fraction ≤ 40%.
•Serum bilirubin, SGOT and SGPT ≤2.5 time the upper level of normal.
•Serum creatinine \< 3.0 or no dialysis.
•NYHA performance status ≥ 3.
•Negative pregnancy test (in women with childbearing potential).
•Subject has read and signed the IRB approved Informed Consent form
•Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Creatinine ≤ 3.0 mg / Dl, and/or no dialysis, INR ≤ 1.6 unless on Coumadin, or PTT \<1.5 x control (to avoid bleeding complications) Patients on Coumadin will be corrected prior to the procedure and must have an INR\<1.6 at the time of randomization/surgery

Exclusion Criteria

•Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study.
•History of Prior Radiation Exposure for oncological treatment.
•History of Bone Marrow Disorder (especially NHL, MDS) that prohibit transplantation.
•History of abnormal Bleeding or Clotting.
•History of Liver Cirrhosis.
•Acute Myocardial Infarction \< 4 weeks from treatment date.
•Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemoccult unless follow-up studies reveal patient to be cancer free.
•Active clinical infection being treated by antibiotics within one week of enrollment
•Terminal renal failure with existing dependence on dialysis
•Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
+10 more criteria

Locations (2)

The Methodist Hospital

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

February 1, 2011

Primary Completion Date

April 1, 2013

Completion Date

April 1, 2013

Last Updated

January 18, 2016

Enrollment

ACTUAL participants

Conditions

Congestive Heart Failure

Interventions

BMAC

BIOLOGICAL

CABG only

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility Study of BMAC Enhanced CABG

Inclusion Criteria

Exclusion Criteria

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